Typically, artificial skin involves application of a collagen scaffold that induces regeneration of skin, specifically for mammals. Treatment of deep skin wounds in adult animals and humans with this scaffold induces regeneration of the dermis. In one commercial embodiment, the artificial skin has been developed commercially under the name Integra™ and is used in massively burned patients, during plastic surgery of the skin, and in treatment of chronic skin wounds.
It is known that successful wound care involves optimizing patient local and systemic conditions in conjunction with an ideal wound healing environment. Many different products have been developed to influence this wound environment to provide a pathogen-free, protected, and moist area for healing to occur. Newer products are currently being used to replace or augment various substrates in the wound healing cascade.
The current state of the art in wound-healing products are applications of antimicrobial silver compounds such as microbial prophylaxis and treatment, negative pressure wound devices, advanced dressings and skin substitutes, biologic wound products including growth factor applications, and hyperbaric oxygen as an adjunct in wound healing. Unfortunately each one of these products addresses only limited factors involved in wound healing and repair. With the design of this novel product, product will bring all these products plus other unique innovations into one single device to provide optimum environment for the proper and rapid wound healing of even non-healing wounds. The present invention is an easily applicable skin barrier with the combination of many of the uniquely designed modalities to optimize wound healing.
Other proposals have involved artificial skin graphs and patches. The problem with these artificial skins is that they do not enable microfluidic characteristics, and the fluids cannot be recorded.
Thus, there are several unmet and unaddressed needs exist in the industry to address the aforementioned deficiencies and inadequacies. Even though the above cited skins meet some of the needs of the market, a scalable microfluidic based artificial skin comprising single or multiple layers of panels fabricated from different inert and biocompatible polymers such as polydimethylsiloxane (PDMS) with microfluidic micro-channels for covering a variety of wounds while also providing efficient healing of the wounds is still desired.
The present invention also utilizes cold micro-plasma capability. Those skilled in the art will recognize that Plasma is one of the four fundamental states of matter, the others being solid, liquid, and gas. Plasma has properties unlike those of the other states. Plasma can be created by heating a gas or subjecting it to a strong electromagnetic field applied with a laser or microwave generator. This decreases or increases the number of electrons, creating positive or negative charged particles called ions, and is accompanied by the dissociation of molecular bonds, if present. The presence of a significant number of charge carriers makes plasma electrically conductive so that it responds strongly to electromagnetic fields. Like gas, plasma does not have a definite shape or a definite volume unless enclosed in a container. Unlike gas, under the influence of a magnetic field, it may form structures such as filaments, beams and double layers. Plasma technology could be effective against pathogenic bacteria with multiple-antibiotic resistance. Another great advantage to cold plasma therapy is that it is non-specific, meaning it is much harder for bacteria to develop resistance. It's a method that is contact free, painless.
Cold plasmas are partially ionized gases, that means only one particle out of 1×109 is ionized. The advantage of cold atmospheric plasmas is that they are “cold”, within the meaning that they operate under room temperature and can be produced at atmospheric pressure on Earth. Cold plasmas with temperatures of 35-40° C. make the technology an attractive option for treating infections. Cold plasmas are able to kill bacteria by damaging microbial DNA and surface structures without being harmful to human tissues. Importantly, it has been shown that plasma is able to kill bacteria growing in biofilms in wounds, although thicker biofilms show some resistance to treatment.
Use of cold plasmas in biology and medicine has recently gained significant interest. One of the most widely discussed potential applications is plasma treatment of infections and wounds for the purpose of reducing microbial load and enhancing healing processes. Lately, the significance of cold plasma (ions, electrons) and ultimately the role of the Reactive Oxygen and Nitrogen Species (RONS) generated in this manner in wound healing have been recognized globally. To this end, there has a great deal of experimentation and exploring by many scientists all over the world. There are currently two German devices that have received European approval of CE Marking. (the equivalent of FDA approval in the US) for chronic wound healing applications. In addition, there is a long history of O3 as a wound healing agent, especially for slowly healing war wounds, dating back to WWI and WWII.
Two major types of plasma treatment have been used in wound disinfection and sterilization. One is indirect treatment using gas flow through plasma which brings mostly neutral active species in contact with living tissue. The other is direct application of non-thermal plasma to living tissues. Indirect treatment permits to decouple plasma system design from constraints related to applying the treatment to living tissues. For example, it permits to employ thermal plasma for generation of active species including substantial quantities of NO.
In direct plasmas the tissue/skin itself serves as an electrode so that in this form current flows through the body. A common example of this is the “dielectric barrier discharge” device (DBD). These discharges are termed barrier discharges, because the electrodes are separated by a non-conducting layer (barrier). The discharges are then not “massive” and possibly catastrophic as in lightning, but “gentle”—in many small micro-discharges of about 100 nanoseconds duration—from the barrier to the opposite electrode. On average an almost homogeneous “carpet” of discharges results—assuming that the distances to the opposite electrode are exactly equal. Typically, the distance between the plasma device and tissue is 1 mm.
Indirect plasmas are produced between two electrodes and then transported to the target area by a gas flow. The individual discharge can be markedly stronger here since there is no interference by a barrier, the transport of the charge carriers and the produced molecules away from the discharge region results simply from the gas flow and from diffusion. Most devices of this type produce thin mm diameter plasma jets, larger surfaces can be treated simultaneously by joining many such jets or by multi-electrode systems. Significantly larger surfaces can be treated than with direct plasmas. Further, the distance between the device and the skin is to a certain degree variable, as the skin is not needed as a plasma electrode, significantly simplifying use on the patient.
It should be pointed out that although O3 has been used in the past and is continued to be used throughout the world (in various forms) for wound treatment (among other applications), the use of controlled microfluidic devices has not been explored. The possibility of using embedded sensors and combining plasma action with other drugs or treatment modalities that have been developed for microfluidic devices makes this a very promising new direction.